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A Comparative Efficacy and Safety Study Between Two Silver Containing Dressings In Post-Op Wound Healing

This study has been terminated.
(The rate of subject recruitment is too slow.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01605968
First Posted: May 25, 2012
Last Update Posted: July 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Chung Shan Medical University
Information provided by (Responsible Party):
Bio-medical Carbon Technology Co., Ltd.
  Purpose

Study objective:

The objective of this study is to evaluate through clinical criteria the clinical efficacy and safety of BCT Silver Bandage role in obstetrical and gynecological wound healing is as effective and safe as Aquacel® Ag. Dressing.

Study devices:

  • Study device: BCT Silver Bandage
  • Comparator device:"ConvaTec"Aquacel® Ag Hydrofiber Dressing

Study design:

  • Randomized, Open-label, interventional, comparative, preventive study with Blinded evaluator.
  • All subjects must meet all the inclusion & exclusion criteria to enter this study in pre-operative phase.
  • Eligible subjects will be enrolled after a scheduled operative procedure.
  • There is SEVEN visits in this study (one screening eligibility phase up to 7 days before OP day, and four post-op treatment scheduled visits consisting on 1st , 3rd day, 5th day, 12th day and two follow up visit on the 28th and the 42nd post-operative day.
  • During each scheduled visit, each subject will have colored picture of his wound after dressing been removed, and on visit V6 for wound evaluation by blinded PI.

Number of subjects: It is expected to recruit ≧150 eligible subjects.

Study Duration: About eighteen month.


Condition Intervention
Surgical Wound Device: BCT Silver Bandage Device: Aquacel® Ag. Dressing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparative Efficacy and Safety Study Between BCT Silver Bandage and Aquacel® Ag. Dressing In Obstetrical and Gynecological Post-Op Wound Healing

Resource links provided by NLM:


Further study details as provided by Bio-medical Carbon Technology Co., Ltd.:

Primary Outcome Measures:
  • Efficacy measurements [ Time Frame: 42 days after operation ]
    1. Wound infection rate within 5 days after operation
    2. Wound healing evaluation by Stony Brook Scar Evaluation Scale (SBSES), to be evaluated by blinded PI at V6
    3. Skin discoloration around the incision wound and/or wound keloid formation rate at V6
    4. Patient and Observer Scar Assessment Scale (POSAS) on V3, V5 and V6


Secondary Outcome Measures:
  • Safety Measurement [ Time Frame: 42 days after operation ]
    The incidence of postoperative skin reactions (defined as blisters, itching, erythematous change around the surgical wound site) within 5 days after operation


Enrollment: 38
Study Start Date: June 2012
Study Completion Date: January 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BCT Silver Bandage Device: BCT Silver Bandage
Activated carbon fiber impregnated with silver particles
Active Comparator: Aquacel® Ag. Dressing Device: Aquacel® Ag. Dressing
Antimicrobial primary dressing incorporating the unique gelling action of Hydrofiber® Technology with ionic silver for wounds that are infected or at risk of infection.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male/Female of any race aged between 18 - 70 years old
  • The subject is willing and able to understand, sign and date the study Informed Consent, and be able to adhere to the scheduled visits regimen.
  • The subject is having surgery (Cesarean pfannenstiel or Open Laparotomy incision) within 1 week

Exclusion Criteria:

  • Patients with known allergy or topical hypersensitivity to ionic silver or alginate
  • Any systemic or local active dermatological disease that might interfere with the evaluation of the surgical site such as eczema, psoriasis, skin cancer, scleroderma, chronic urticarial
  • Patients undergoing MRI (Magnetic Resonance Imaging) examination.
  • Subject residence is outside the study center city
  • Patients was participating in another clinical trial less than 30 days before participation in this trial
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01605968


Locations
Taiwan
Dep. of Gynecology and Obstetrics, Chung-Shan Medical University Hospital
Taichung City, Taiwan, 40201
Sponsors and Collaborators
Bio-medical Carbon Technology Co., Ltd.
Chung Shan Medical University
Investigators
Principal Investigator: Chih-Jen Tseng, MD Dep. of Gynecology and Obstetrics, Chung-Shan Medical University Hospital
  More Information

Responsible Party: Bio-medical Carbon Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT01605968     History of Changes
Other Study ID Numbers: CS11176
First Submitted: May 23, 2012
First Posted: May 25, 2012
Last Update Posted: July 14, 2017
Last Verified: July 2017

Keywords provided by Bio-medical Carbon Technology Co., Ltd.:
Obstetrics
Gynecology
Wound healing

Additional relevant MeSH terms:
Wounds and Injuries
Surgical Wound
Carboxymethylcellulose Sodium
Laxatives
Gastrointestinal Agents